MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 150MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical products: item#: 14-405034, ti-dble lead cort 5.0x34mm scr; lot#: 682140.Item#: 14-405046, ti-dble lead cort 5.0x46mm scr; lot#: 279990.Item#: 14-405032, ti-dble lead cort 5.0x32mm scr; lot#: 722300.Item#: 14-405046, ti-dble lead cort 5.0x46mm scr; lot#: 715590.Item#: 14-405070, ti-dble lead cort 5.0x70mm scr; lot#: 365010.Item#: 110007912, cann screw 8.0mmx75mmx16mm; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not released to customer per hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a planned explantation of a short term nail which was being replaced by a plate.While explanting the nail the distal portion fractured.No foreign body was retained by the patient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g1-2; g3; g6; h1; h6 h6: component code: mechanical (g04) - im nail visual examination of the provided pictures identified the device is fractured, however as the product was not returned further visual and dimensional analysis could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ANKLE LOCKING NAIL 11 X 150MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 13535858
• Report Number: 0001825034-2022-00336
• Device Sequence Number: 4227861
• Product Code: HSB
• UDI-Device Identifier: 00887868093593
• UDI-Public: (01)00887868093593(17)280411(10)894840
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-440215
• Device Lot Number: 894840
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male